1. Field of the Invention
The present invention relates to medical diagnostics, and in particular, to ingestible medical diagnostic devices.
2. Background Art
The population of the United States is aging. The first wave of the 78 million “Baby Boomers” is beginning to turn 60 years old. Coinciding with this aging of population is a rising concern regarding the public health, and a generally more educated patient in technology awareness. There has been an explosion in diabetes cases, estimated at 194 million cases worldwide today, and predicted to be 350 million cases by year 2025. Obesity currently affects two thirds of the U.S. population. There is a rising incidence of cardiac problems for women (the #1 cause of death for women). Hepatitis C will soon reach epidemic levels, infecting nearly 5 million people, more than the number of approximately 1.2 million people infected with HIV/AIDS in the U.S. Celiac disease affects approximately 2.2 million people in the U.S., with about 97% being undiagnosed. The prevalence of further serious conditions, such as colon cancer, other cancers, ultra- or ulcerative-colitis, lactose intolerance, allergies, irritable bowel syndrome, Crohn's disease, etc., indicate that there is a need for simple and easy diagnostic techniques, especially because many of these diseases are chronic, requiring repeat testing over time. Some conditions, such as cancer, are most responsive to treatment if caught in the early stages. Cancer, for example, is best detected in the digestive tract. Given that cancerous growth can occur in as little as one to two years, it is essential to detect cancer or cancerous precursors at least annually, or preferably biannually. Physician and health care resources are currently already stretched and will fail if the current technology, process and procedure are not altered to suit the needs of the baby boomer market of the near future. Time-saving and simple solutions to diagnostics are needed.
The current population desires speedy testing and fast answers to their health questions. Many current testing and monitoring systems are limited by old technology and processes that takes days if not weeks for results. These test methods if not inconvenient and potentially embarrassing are at least in most cases intrinsically painful or risky to patients.
One ingestible diagnostic device in the market today is a disposable camera pill or capsule camera, which captures images of the small intestines as it passes through. Camera pill usage by patients and physicians is limited in many different ways. The current camera pill systems require a bulky reading device worn as a belt around the waist and adhesive sensors attached to the body to capture the electromagnetic inductively coupled signal sent from the pill. The patient is required to report to a physician's office to initiate use of the camera pill, and to be fitted with the belt reader. The reader belt is worn for 24 hours, during which time the camera pill captures images and transmits the images to the reader belt. At the end of a diagnosis period, the belt reader is returned to the physician. The physician downloads images from the belt reader and analyzes the images. Thus, the camera pill requires at least two trips to the physician's office, as well the wearing of a cumbersome reader belt with leads attached to the skin. This diagnostic process is both inconvenient and uncomfortable. Furthermore, the current camera pill is an expensive device, and is resorted to when other bowel disease diagnostic techniques, such as endoscopy and colonoscopy, present results that need further investigation. Additionally, the camera pill senses visible (white) light spectrum, which is not itself a direct indicator of a specific disease or chemical inbalance. Therefore, the ingestible camera pill has significant deficiencies.
Thus, what is needed are diagnostic devices, services and processes that are simple, convenient, relatively inexpensive, comfortable, take less time, directly detect specific compounds or indicators to disease, and have more applications.